An interventional study of Physiotherapy Program and Biopsychosocial Intervention in Temporomandibular Disorders (TMD), sponsored by Betül Özata. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Betül Özata · Not applicable, Interventional, and Treatment
Temporomandibular disorders are conditions that affect the jaw joint and surrounding muscles and may cause pain, limited jaw movement, stress, sleep problems, and teeth grinding. Physiotherapy is commonly used to manage these problems, but psychological and social factors may also influence symptoms.
The purpose of this study is to examine whether adding a biopsychosocial approach to physiotherapy improves stress levels, sleep quality, and bruxism in individuals with temporomandibular disorders. Participants will receive either physiotherapy alone or physiotherapy combined with education about pain, stress management, and sleep habits. The results of this study may help improve treatment strategies for people with temporomandibular disorders.
This randomized interventional study aims to investigate the effects of adding a biopsychosocial approach to physiotherapy in individuals with temporomandibular disorders. Temporomandibular disorders are multifactorial conditions influenced by physical, psychological, and social factors. While physiotherapy is effective in reducing pain and improving function, psychosocial factors such as stress, sleep disturbance, and bruxism may contribute to symptom persistence.
Participants will be randomly assigned to one of two groups. The control group will receive a standardized physiotherapy program including therapeutic exercises and manual therapy targeting the temporomandibular joint and related musculoskeletal structures. The intervention group will receive the same physiotherapy program in addition to a biopsychosocial intervention consisting of pain neuroscience education, stress management strategies, and sleep hygiene education.
Outcome measures will include stress levels, sleep disturbance, and bruxism severity as primary outcomes, and pain intensity and jaw function as secondary outcomes. Assessments will be conducted at baseline and after the intervention period. This study is expected to provide evidence on the effectiveness of integrating a biopsychosocial approach into physiotherapy for temporomandibular disorders.
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
This study's planned enrollment of 40 is below the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →This is the only study on the registry with Betül Özata as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive a standardized physiotherapy program for temporomandibular disorders, including therapeutic exercises and manual therapy targeting the temporomandibular joint and associated musculoskeletal structures.
Other: Physiotherapy Program
Participants in this arm will receive the same physiotherapy program combined with a biopsychosocial intervention including pain education, stress management strategies, and sleep hygiene education.
Other: Physiotherapy Program · Other: Biopsychosocial Intervention
A standardized physiotherapy program including therapeutic exercises and manual therapy targeting the temporomandibular joint and related musculoskeletal structures.
A biopsychosocial intervention including pain neuroscience education, stress management strategies, and sleep hygiene education.
Stress Level
Stress level will be assessed using a validated self-reported questionnaire to evaluate perceived stress in individuals with temporomandibular disorders.
Time frame: Baseline and 6 weeks
Sleep Disturbance
Sleep disturbance will be assessed using a validated questionnaire evaluating sleep quality and sleep-related problems.
Time frame: Baseline and 6 weeks
Bruxism Severity
Bruxism severity will be evaluated based on self-reported measures assessing teeth grinding and clenching behaviors.
Time frame: Baseline and 6 weeks
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared because the study involves sensitive personal and health-related information, and data sharing was not included in the original ethical approval. Data will be used solely for the purposes of this study and related scientific publications.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Temporomandibular Joint Disorders →